Study of DTRI-031 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers; Pharmacokinetics; Pharmacodynamics
• Interventions: Drug: DTRI-031; Drug: Placebo

• Registration Number: NCT05005520
• Lead Sponsor: Basking Biosciences, Inc.

Brief Summary

A randomized, double-blind, single center, placebo-controlled phase 1 study in healthy volunteers to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous (iv) injection of DTRI-031

Detailed Description

Up to 5 cohorts of 8 healthy volunteers for a total of 40 volunteers will be randomized to either DTRI-031 or matching placebo (6 active:2 placebo). Two sentinel subjects, one randomized to each group, will be dosed at least 1 day prior to dosing of the remaining subjects in a cohort.

Subjects will complete a screening visit up to 28 days prior to administration of study drug to confirm eligibility. Eligible subjects will arrive at the phase 1 unit up to 24 hours prior to Day 1 and remain until completion of 24-hour assessments. Subjects will return for a Day 7 follow-up visit and receive a safety assessment telephone call on Day 28.

A Safety Review Committee will review individual subject and aggregate group safety data following each dose-based study cohort and recommend whether the trial should continue to the next cohort.

Study Timeline

• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-13
• Study Start: 2021-10-20
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• 18-55 years of age
• Ability to provide written consent
• Weight 50-110 kg with BMI 18.5-32 kg/m2
• Willingness to use contraceptives
• Negative COVID-19 test
• Negative results for alcohol and drugs of abuse

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Exclusion Criteria

• Pregnant or lactating females
• Familial bleeding disorder or individual or family history of bleeding diathesis or coagulopathy
• Females with active menstruation on day of dosing
• Use of prescription medications known to affect platelet function
• Use of NSAIDs, aspirin, anti-platelet or anti-coagulation therapy within 10 days of dosing
• Contraindication to anticoagulation or increased bleeding risks
• History of thrombocytosis, high platelet count, intracranial bleeding, aneurysm, stroke, vascular disease
• History of peptic ulcer disease, gastrointestinal or genitourinary bleed, severe trauma, fracture, major surgery of biopsy of parenchymal organ within past 3 months
• Planned surgery during the study
• Any clinical significant abnormality at screening
• Use of investigational drug in past 30 days or 5 half lives
• Concurrent enrollment in another clinical study or more than 3 clinical studies in past 12 months
• Any prior history of substance abuse or treatment or positive urine screen for drugs of abuse or positive breathalyzer test

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: Single ascending dose DTRI-031	DTRI-031	Drug: DTRI-031 Single doses of DTRI-031 delivered via intravenous injection. Ascending dose levels will be evaluated.
Placebo Comparator: Single Dose Placebo	Placebo	Drug: Placebo Single doses of placebo delivered via intravenous injection, matched to DTRI-031 cohorts

Primary Outcome Measures

Name	Time	Method
Safety as assessed by adverse events (AEs)	From dosing (DTRI-031 or placebo) to final visit (Day 28)	Incidence of treatment-emergent AEs

Secondary Outcome Measures

Name	Time	Method
Platelet Function	From dosing to 24 hours after dosing	Whole blood platelet function closure times
Plasma von Willebrand Factor (vWF) levels	From dosing to 24 hours after dosing	Level of vWF following single administration of drug
Pharmacokinetics as measured by DTRI-031 plasma levels	From dosing to 24 hours after dosing	Plasma concentration of DTRI-031 (after single dose of drug)

Trial Locations

Locations (1)

Nucleus Network; 🇦🇺 Melbourne, Victoria, Australia